MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN LEGION TOTAL KNEE PRIM FEM COMP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)

Event Date 10/11/2020

Event Type  Injury  

Event Description

On the literature article named "small soft tissue tension changes do not affect patient-reported outcomes one year after primary tka", it was reported that, after a legion system had been implanted, one patient from the study group (elevated soft tissue tension) underwent a postoperative manipulation under anesthesia on the knee due to unspecified reasons.No further information regarding the event was reported.The outcome of the patient is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, after a legion system had been implanted, one patient from the study group (elevated soft tissue tension) underwent a postoperative manipulation under anesthesia on the knee due to unspecified reasons.However, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN LEGION TOTAL KNEE PRIM FEM COMP
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12119134
• MDR Text Key: 260036250
• Report Number: 1020279-2021-05704
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN LEGION TOTAL KNEE PRIM COUPLER/UNK; UNKN LEGION TOTAL KNEE PRIM STEM/UNK; UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE/UNK; UNKN LEGION TOTAL KNEE PRIM TIB INSERT XLPE/UNK
• Patient Outcome(s): Other